Traditionally, a syringe is filled manually by aspirating a liquid pharmaceutical component from a pharmaceutical vial having a neck with a penetrable closure into the syringe through a needle that penetrates the penetrable closure. The method of manually filling the syringe typically includes the following steps: (a) drawing air into the body of the syringe by pulling the syringe's plunger away from the needle end of the syringe until the volume of air in the body approximately equals the volume of pharmaceutical component to be loaded into the syringe; (b) carefully aligning the needle with the vial's penetrable closure and inserting the needle through the penetrable closure into the vial; (c) inverting the vial and forcing the air from the body of the syringe into the vial by advancing the syringe's plunger; (d) withdrawing the plunger to draw out the desired volume of the pharmaceutical component into the syringe; and (e) removing the needle from the vial.
This method suffers from various disadvantages. Firstly, the user is exposed to the unprotected needle tip, which can result in accidental stabbings or prickings to the user. Secondly, if the user wishes to draw a large volume of the pharmaceutical component into the syringe (e.g., 10 cc) an equivalent volume of air must be forced into the vial. This can increase the pressure in the pharmaceutical vial to the point where the pharmaceutical component may spray through the puncture point made by the needle in the penetrable seal and onto the user. These accidents are particularly dangerous if the pharmaceutical component is unsafe to the user, for example where it includes toxic oncology pharmaceuticals. Thirdly, the sterility of the needle may be compromised during the process of transferring the pharmaceutical component from the vial to the syringe.
Additionally, many pharmaceutical preparations must be distributed and stored as two or more separate components, for example such as a solid lyophilized component and a liquid component. The two components are mixed just prior to administration. In the case of a solid and liquid component, the pharmaceutical preparation may be reconstituted by: (a) providing a first solid component packaged in a pharmaceutical vial having a neck closed by a penetrable closure; (b) providing a second liquid component in a syringe; (c) injecting the second liquid component into the vial through the penetrable closure; (d) swirling the vial impaled on the syringe to dissolve, dilute or suspend the first solid component in the second component; and (e) aspirating the combined components back into the syringe. Alternatively, the two or more components may be liquid and require mixing just prior to administration. The mixing may be accomplished in an analogous manner. These methods suffer from many of the disadvantages described above.
Some medical treatments require the administration of a relatively small dosage of a pharmaceutical composition. Examples of such medical treatments include, but are not limited to, ocular treatments, ovulation induction treatments, tuberculin tests, and diabetes treatment. In some cases, the composition can be relatively viscous, which may tend to cause some of the composition to remain or be “held up” in the vial. These types of pharmaceutical compositions tend to be very expensive both to manufacture and administer. For these reasons, it is desirable to minimize the volume of pharmaceutical composition that is “held up” or left behind in the dispensing container.
For vials containing a pharmaceutical component in lyophilized form, there can be a tendency of the pharmaceutical component to cake onto the inner walls of the vial during lyophilization. Such caking of the lyophilized pharmaceutical component on the vial walls can make mixing of the component with a diluent more difficult.